Clearly we are losing the battle against obesity, diabetes, and Alzheimer. Part of the problem is that we don't focus enough on preventative, but wait until a patient has an issue, and then treat it. I know this is the case with my doctor and I'm sure with most, because of time restrictions. T levels across the board are dropping in men compared to 40 years ago, mainly due to increasing BMI. This is why the largest percentage increases of men on TRT is less than 55 years of age. Problem is, the age in which men become fathers is also increasing. Putting more younger men on TRT that is #$%$ down sperm production is only making the issue worse, as far as reproduction. Certainly the FDA has to realize Endroxal is the only treatment that solves all three issues, BMI, T levels, and sperm production. Even if you take reproduction out of the equation, a man feels his best sexually when the genitals are at peak performance. If size and performance are being compromised by TRT, it's going to effect a man mentally. The old saying is that over 90% of sex takes place in the head.
Sentiment: Strong Buy
This is what the FDA is facing. people with type 2 diabetes are twice as likely to develop Alzheimer’s, that's why many neurologists call Alzheimer’s, Type 3 diabetes. More than half of USA adults have metabolic syndrome, which leads to type 2 diabetes after about 7 years of having metabolic syndrome. So the wave of coming diabetes will lead to an even greater problem of Alzheimer’s. Perhaps the new VA study will help get the FDA to keep therapies like Endroxal and TRT moving forward to help with the coming crisis.
The sooner Endroxal gets labeled a preventative medicine, the better.
One more reason to watch the waistline: New research says people's weight in middle age may influence not just whether they go on to develop Alzheimer's disease, but when..
Nearly 47 million people now have dementiaHealthNearly 47 million people now have dementiaSee all relatedí
Obesity in midlife has long been suspected of increasing the risk of Alzheimer's. Researchers at the National Institutes of Health took a closer look and reported Tuesday that being overweight or obese at age 50 may affect the age, years later, when Alzheimer's strikes. Among those who eventually got sick, more midlife pounds meant an earlier onset of disease.
Study: Women with mild memory problem worsen faster than men
Study: Women with mild memory problem worsen faster than men
It will take larger studies to prove if the flip side is true — that keeping trim during middle age might stall later-in-life Alzheimer's. But it probably won't hurt.
"Maintaining a healthy BMI at midlife is likely to have long-lasting protective effects," said Dr. Madhav Thambisetty of NIH's National Institute on Aging, who led the study reported in the journal Molecular Psychiatry.
About 5 million people in the U.S. are living with Alzheimer's, a number expected to more than double by 2050, barring a medical breakthrough, as the population ages.
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Alzheimer's starts quietly ravaging the brain more than a decade before symptoms appear. With a cure so far elusive, researchers are hunting ways to at least delay the disease, and lifestyle changes are among the possible options.
Sentiment: Strong Buy
[Organic erectile dysfunction and metabolic syndrome in young and middle-aged men: analysis of 154 cases].
Zhonghua Nan Ke Xue. 2014 Nov;20(11):999-1003.
To investigate the association of erectile dysfunction (ED) with metabolic syndrome ( MS) and the total testosterone ( tT) level in young and middle-aged men.
This study included 154 organic ED outpatients aged 20 -59 years and 103 age-matched men with normal sexual life. We obtained their waist circumference ( WC) , blood pressure ( BP) , fasting blood glucose ( FBG) , triglyceride ( TG) , high density lipoprotein ( HDL) , tT, IIEF -5 score, erectile function indexes and other relevant variables, and compared them between the ED and non-ED groups as well as between the ED patients with MS and those without MS.
The prevalence of MS is significantly higher in young and middle-aged ED patients than in normal males, and MS is associated with a lower testosterone level and poorer erectile performance. Central obesity is closely correlated with ED in young and middle-aged men.
They blew it. Not just a little but royally. Not sure what compass you're working with. You're very much off base. If the market thought the NDA was clean and your analysis were right on the money, this stock would be many fold higher than now but it isn't. It is too late in my opinion but if they had any sense they would have worked with a back up product option, it if is weight loss or some other indication that could have been proven symptomatically that would have sufficed but right now I don't see a clear path to approval.
The FDA has had plenty of concerns over Androxal. The multiple trials should not have happened. It was pretty much Repros being dragged around without a firm agreement what the actual product definition is. Repros decided to file the NDA on a let's agree to disagree basis and it appears it is based on hoping the FDA changes its mind based on the battery of studies out there showing that testosterone therapy has long term benefits all of which the FDA and advisory committee has gone on record stating emphatically that they don't see it. I don't like it either but it seems to be the reality of the regulatory body for the time being.
no they didn't blow it, if anything the FDA moved the goal post, because up until the advisory committee in Sept. 2014, the FDA never asked for more benefits than the primary endpoints established over multiple trials. So show me one statement by the FDA that Endroxal would be considered in the same way as TRT, having to show benefit in aging men beyond raising T and preserving fertility. Furthermore , the new labeling does address that issue by excluding aging men.
you simply cannot extrapolate or make assumptions on the benefits. they need to be proven. Repros management really blew it. they may have something but they need to prove it. it is that simple.
Again, certainly if the approve use for the reduction in weight, that could be an application and then at the doctor's discretion they can prescribe for other issues relating to weight or say diabetes but right now there is no basis for approval for anything. the FDA and their advisory committee on testosterone make it very clear they don't see any benefits and for many people as far as they know lowered t levels is normal while many doctors like Morgantaler would refute this.
Need placebo controlled mask study and monitor all relevant symptomatic data to yield proper conclusion.
Remember diets should be controlled in studies.
Excellent points hiwatt, I totally agree.
It would make alot of sense for the FDA to approve Endroxal based on the new label and allow Repros to pursue metabolic indicators in future studies.
most are careful, is that why 27% of patients on TRT did not even have a single blood test, that makes no sense.
I'm not suggesting in Nov Endroxal will be approved for anything other than 2nd HG under 60 who want to preserve fertility. Endroxal approved for any metabolic indication is obviously a long way off, but possible.
Nov should be a first step for Endroxal which is better treating 2nd HG and serving the FDA's purpose, to curb over prescribing of TRT.
There are side benefits Repros can point to, in terms of BMI, glucose level and LDL and with the new VA study long term CV benefit with normalization of T level without chemically castrating the patient.
This reduction, along with a reduction in blood sugar, after only 6 months of treatment is clearly a symptomatic benefit for an obese man. Most of the benefits from T come from several years of treatment as shown in the 5 year studies, whereas most clinical trials only last a year or less. The 21% reduction in LDL after only 6 months is compatible with a low dose statin, but with the reduction in blood sugar makes it superior. Weight loss will be a little tricky to prove since most men are changing fat into muscle mass and therefore not reducing weight that much, just getting in better shape.
Sentiment: Strong Buy
Trt is not abused as a clinical expert. Most doctors are careful.
The issue is the fda doesn't buy into it. The reason why the fda doesn't say that testosterone should be used for diabetes is because that indication was never sought.
By the same token Endroxal won't be approved for treating hypogonadism patients who are obese. No established benefits . If on the other hand Endroxal was approved for managing diabetes, doctors using anecdotal data could prescribe it off label for weight problems.
I absolutely agree, he would have to prove any weight loss benefits with future studies. But Repros should not be responsible to prove the benefits of normalizing testosterone levels because the TRT companies have abused their labeling and marketed TRT to all men, regardless of blood testing.
Especially since Clomid with a long track record is not TRT, why should Repros be singled out.
Meanwhile TRT is not being taken off the market or restricted in any way besides labeling and a future CV study by the big companies. Plus the recent VA study justifies the continued prescribing, and further validates the benefits of normalizing T-levels in the right way based on testing. Why should it all be on Repros, it makes no sense. The right thing to do is approve it based on the new label and keep developing it.
Fda will say that if Joe thinks Endroxal lowers cholesterol he needs to prove it. It is too loosely tied correlation not direct evidence in their NDA. We can speculate benefits all day in the literature.
the point also is that the FDA has been looking for ways to address the metabolic syndrome crisis, over 50% of adults in USA have it, , so lets compare the newly approved weight loss drug qsymia to testosterone.
the 6 yr aveed study showed - 15% weight loss on average
qsymia 2 yr trial - showed 5% to 10% weight loss with lots of side effects
isn't the FDA at least curious since the approval of 3 new weight loss drugs is not proving to be successful
the point is that statins do not change insulin resistance, the real underlying cause of obesity and CV events not cholesterol. 50 % of men who die form heart attacks have normal cholesterol, inflammation and insulin resistance is a much better marker. the drop in heart attacks since stains were introduced is more likely due tho the drop in smoking.
Raising testoterone to normal levels is proving to be actually beneficial in terms of CV events as shown in the VA study. So you cannot say that after the Adcom the FDA will have the exact same stance that they had a year ago, things are changing. Could they ask for more clinical benefits data, possibly, that is the risk in this situation,. However you ignore all evidence over the last year that there are advantages to the FDA's goals and to patients for approving Endroxal for the new label, and then moving it forward by approving the IND for weight loss.
Statins and low t drugs are very different and you cannot make such comparisons. Doctors won't buy into this because it has not been proven. Assuming fda thinks Endroxal is approvable which is unlikely the fda will reserve judgement on its overall benefits and long term safety.
this all leads to a good question, If you are a guy with low T and low LH and high BMI and a bad lipid profile, what drug would you choose to lower insulin resistance(the cause of metaboloic syndrome) and increase T level:
1. Statins - can cause diabetes and memory loss
2. TRT - lowers LH even more causing a dependency and shrinks the balls
3. Endroxal - increases T, preserves LH, improves physical energy and ED function getting you off the couch to start a better diet and exercise program to lower insulin resistance even more.
don't know about you but I like #3